An integrated analysis system for the rapid analysis, recording, and transmission of host biometric data is provided. The method comprises introducing an aqueous biological material through a vertical passageway into a fully enclosed flow chamber, where a central hub distributes the material radially through integrated flow channels. The material is received into microtubes and analyzed by embedded medical diagnostic sensors to simultaneously measure physical and chemical parameters, including quantitative optical measurements, without prior analyte concentration or separation. The method includes storing collected data on an internal memory cartridge and executing real-time predictive analytics via a remote AI processing unit in wireless communication with the system. Final diagnostic results are transmitted via a wireless transmitter, providing stationary sensor analysis from clinical specimen collection equipment, such as a manual user-actuated syringe, coupled to the chamber's injection point.
Legal claims defining the scope of protection, as filed with the USPTO.
providing a fully enclosed flow chamber having a top surface, a bottom surface, and an interior space defined between the top and bottom surfaces; introducing an aqueous biological material through a passageway extending along a substantially vertical axis through the flow chamber, the passageway comprising a substantially circular hollow tube defining an injection point at the bottom surface; distributing the biological material through a central distribution hub located within the interior space and fluidly connected to the passageway; directing the biological material through a plurality of flow channels monolithically integrated within the flow chamber and extending radially from the central distribution hub; receiving the biological material into a plurality of microtubes located at outer ends of the flow channels, the microtubes comprising interior compartments; analyzing the biological material via at least one medical diagnostic sensor embedded within the interior compartments of the microtubes; storing data on at least one memory cartridge attached to the fully enclosed flow chamber; and processing data via a remote access device comprising artificial intelligence (AI) processing units in wireless communication with the memory cartridge and the medical diagnostic sensor; wherein the injection point receives the aqueous biological material from a clinical specimen collection equipment removably attached thereto, such that a pump force moves the biological material from the injection point, through the central distribution hub, and into the plurality of microtubes for stationary sensor analysis. . A method for integrated blood analysis using an integrated analysis system, the method comprising:
claim 1 . The method of, wherein the fully enclosed flow chamber is composed of a biocompatible material.
claim 1 . The method of, wherein the plurality of microtubes are positioned below a vertical plane of the central distribution hub and beneath the top surface of the flow chamber, such that the structural arrangement prevents flow reversal of the aqueous biological material.
claim 1 . The method of, further comprising forming a hermetic seal at the injection point of the passageway via a female Luer lock connector configured to receive a corresponding male Luer connector of the clinical specimen collection equipment.
claim 1 . The method of, further comprising sealing the radial arrangement of the flow channels and microtubes via a glass slide horizontally extending across the top surface of the flow chamber and fixed thereon.
claim 1 . The method of, further comprising performing quantitative measurements of the biological material via an optical sensor without prior analyte concentration or separation.
claim 1 . The method of, further comprising measuring at least one physical parameter and at least one chemical parameter of the aqueous biological material simultaneously using electrochemical principles via the medical diagnostic sensor.
claim 1 . The method of, further comprising transferring data between the memory cartridge and the medical diagnostic sensor via a local internal bus within the sealed flow chamber.
claim 1 . The method of, further comprising executing predictive analytics via the AI processing unit to analyze biometric data in real time and transmitting final diagnostic results, rather than raw sensor data, via a wireless transmitter.
claim 1 . The method of, further comprising performing individual preliminary analysis of the aqueous biological material across at least five distinct analysis points via the plurality of microtubes.
claim 1 . The method of, further comprising connecting at least one of the medical diagnostic sensors to a host to track in vivo and in vitro physical parameters.
claim 1 . The method of, further comprising providing the pump force insertion via a pre-filled syringe containing the aqueous biological material, the syringe comprising a manual user-actuated plunger mechanism coupled to the injection point.
claims 1, 2, or 3 . The method of any one of, further comprising distributing the material simultaneously into the plurality of flow channels via the central distribution hub located within the interior space in fluid communication with the vertical passageway.
claims 1, 2, or 3 . The method of any one of, further comprising coupling an outlet of a pre-filled syringe containing the aqueous biological material to the injection point of the passageway, the syringe comprising a barrel and a plunger.
claims 1, 2, or 3 . The method of any one of, further comprising performing quantitative measurements on the material within the flow channel via a plurality of optical sensors without prior analyte concentration or separation.
Complete technical specification and implementation details from the patent document.
This application claims priority to U.S. Utility patent application Ser. No. 18/530,167 filed Dec. 5, 2023, now pending.
The present disclosure relates to an integrated analysis system and method for the rapid measuring and recording of data from a host. More particularly, the subject matter relates to a fully enclosed flow chamber configured for the radial distribution of an aqueous biological material from a central distribution hub into a plurality of microtubes for stationary sensor analysis. The disclosure further relates to the integration of medical diagnostic sensors, memory cartridges, and remote access devices comprising artificial intelligence (AI) processing units configured for the wireless communication and predictive analytics of biometric data.
In the field of medical diagnostics, there is an increasing demand for accurate, rapid, and efficient systems capable of measuring and recording data from biological materials for tracking, measuring, and monitoring purposes. Conventional methods often involve time-consuming processes and may lack the ability to provide real-time and in-depth analysis of biological samples.
To address these challenges, various sensors and diagnostic tools have been developed to measure specific parameters of biological materials, such as density, flow rate, cellular features, and oxygen levels. Additionally, advancements in artificial intelligence have provided opportunities to enhance the analysis and interpretation of complex datasets derived from biological samples.
Furthermore, the integration of memory storage devices with analysis systems has become crucial for efficiently storing and accessing large volumes of data generated during the measurement and recording processes, enabling subsequent retrieval and analysis.
In order to accomplish the objectives of the present disclosure, there is provided a method for integrated blood analysis using a system that includes a fully enclosed flow chamber with a vertical passageway for introducing aqueous biological material via an injection point. The material is then distributed through a central hub, directed radially through flow channels, and received into microtubes containing embedded medical diagnostic sensors for analysis. Data from the sensors is stored on memory cartridges and processed wirelessly by a remote access device with AI units for predictive analytics and transmission of diagnostic results. The system uses a specific structural arrangement to prevent flow reversal and performs simultaneous physical and chemical parameter measurements. The method can use optical sensors for quantitative measurements without prior analyte concentration and supports tracking in vivo and in vitro parameters
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of any described embodiment, suitable methods and materials are described below. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. In case of conflict with terms used in the art, the present specification, including definitions, will control.
The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description and claims.
The following detailed description is the best-contemplated mode of carrying out the disclosure. Although the disclosure has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention.
To facilitate a clearer understanding of the integrated analysis system, the following definitions are provided for terms used throughout the specification and claims:
Aqueous biological material refers to any fluid specimen derived from a biological source, including but not limited to whole blood, plasma, serum, urine, saliva, or clinical samples in an aqueous carrier.
Central distribution hub refers to a structural distribution junction or hub within the flow chamber that receives fluid from a single input passageway and branches it out into multiple distinct flow channels.
9 FIG. 66 Pump force refers to the mechanical pressure applied to a fluid to initiate movement through the system, which may be generated by a manual plunger as shown in, element.
Stationary sensor analysis is a method of measurement where the biological material remains substantially at rest within a sensing compartment during the time period in which data is captured by the medical diagnostic sensors.
Artificial Intelligence (AI) Processing Units refers to hardware and software components, including machine learning algorithms and predictive analytics, configured to process complex biometric data to generate diagnostic results.
Hermetic seal is a vacuum-tight or air-tight structural connection that prevents the leakage of fluids and prevents the entry of external contaminants.
10 12 14 16 18 14 16 44 20 12 20 22 24 16 44 26 18 20 28 12 26 The present disclosure provides a method for integrated blood analysis using an integrated analysis system. The method begins by providing a fully enclosed flow chamberhaving a top surface, a bottom surface, and an interior spacedefined between the topand bottom surfaces. An aqueous biological materialis introduced through a passagewayextending along a substantially vertical axis through the flow chamber, where the passagewaycomprises a substantially circular hollow tubedefining an injection pointat the bottom surface. The method includes distributing the aqueous biological materialthrough a central distribution hublocated within the interior spaceand fluidly connected to the passageway, and subsequently directing the material through a plurality of flow channelsmonolithically integrated within the flow chamberextending radially from the central distribution hub.
44 30 32 28 30 34 36 24 44 46 24 26 30 12 48 30 50 26 14 44 The method further comprises receiving the aqueous biological materialinto a plurality of microtubeslocated at outer endsof the flow channels, where the microtubescomprise interior compartmentshousing at least one medical diagnostic sensor. In operation, the injection pointreceives the aqueous biological materialfrom a clinical specimen collection equipmentremovably attached thereto, such that a pump force moves the material from the injection point, through the central distribution hub, and into the plurality of microtubesfor stationary sensor analysis. The method utilizes a flow chamberpreferably composed of a biocompatible material. By positioning the plurality of microtubesbelow a vertical planeof the central distribution huband beneath the top surface, the method effectively prevents flow reversal of the aqueous biological material.
24 52 54 46 56 14 28 30 44 36 68 68 38 36 58 12 To ensure a secure environment, the method includes forming a hermetic seal at the injection pointvia a female Luer lock connectorconfigured to receive a corresponding male Luer connectorof the clinical specimen collection equipment. A glass slideis fixed horizontally across the top surfaceto seal the radial arrangement of the flow channelsand microtubes. The method involves analyzing the aqueous biological materialvia the medical diagnostic sensor, which may perform quantitative measurements as an optical sensor without prior analyte concentration or separation, or measure at least one physical parameterand chemical parametersimultaneously using electrochemical principles. Data is transferred between a memory cartridgeand the medical diagnostic sensorvia a local internal buswithin the sealed flow chamber.
40 42 38 36 42 68 60 44 30 36 62 68 64 24 66 For advanced data handling, the method includes processing data via a remote access devicecomprising artificial intelligence processing unitsin wireless communication with the memory cartridgeand the medical diagnostic sensor. The artificial intelligence processing unitsexecute predictive analytics to analyze biometric parametersin real time and transmit final diagnostic results via a wireless transmitter. The method allows for individual preliminary analysis of the aqueous biological materialacross at least five distinct analysis points via the plurality of microtubes. Furthermore, the method may include connecting at least one medical diagnostic sensorto a hostto track in vivo and in vitro physical parameters. The pump force may be provided by coupling a pre-filled syringeto the injection pointand actuating a manual user-actuated plunger mechanism.
70 72 36 44 68 40 70 36 The method is designed to rapidly capture measured signalsand communicate them through various interfacesto enable timely results in emergency or remote settings. The medical diagnostic sensorsare exposed to biological materialssuch as blood, urine, or saliva to measure parameterssuch as analytes, blood gases, and hematocrit levels. The remote access deviceutilized in this method may include a cell phone or computer for capturing and communicating the measured signalsfrom the medical diagnostic sensors.
10 18 12 36 44 26 30 34 The methodology of the integrated analysis systemcan incorporate the use of Micro-Electro-Mechanical Systems (MEMS) technology to fabricate microscopic mechanical and electromechanical elements directly into the interior spaceof the fully enclosed flow chamber. In such an embodiment, MEMS-based components could function as a medical diagnostic sensorto perform real-time hemodynamic monitoring, thereby measuring the precise pressure and flow rate of the aqueous biological materialas it moves from the central distribution hubinto the microtubes. This approach potentially allows for high-accuracy cell counting by detecting electrical resistance changes as individual cells pass through micro-apertures within the interior compartments. As an alternative to MEMS, the system could utilize Microfluidic Surface Acoustic Wave (SAW) sensors to manipulate and sense particles using sound waves, or Photonic Crystal sensors to detect biological binding events through light-trapping structures.
30 28 68 34 36 The methodology can further provide for the possible incorporation of electrophoresis to separate and quantify specific proteins or hemoglobin variants within the microtubes. By optionally applying a controlled electric field across the flow channels, the system could exploit the charge-to-size ratio of molecules to move them at different rates, facilitating the identification of specific parameters. In the context of the radial flow design, this electrophoretic process could serve as a secondary sorting step to refine analytes after they reach the interior compartments, allowing for highly sensitive quantitative measurements without requiring prior off-chip concentration. Alternatives to electrophoresis include dielectrophoresis (DEP), which uses non-uniform electric fields to move uncharged particles, and magnetophoresis, which utilizes magnetic bead tagging to pull specific analytes toward the medical diagnostic sensorusing external magnetic gradients.
44 12 20 30 70 36 44 48 Additionally, the methodology could employ heparinization to maintain the fluid integrity of the aqueous biological materialthroughout the analysis process. By optionally coating the interior surfaces of the fully enclosed flow chamber, the passageway, and the microtubeswith heparin, the system provides a means to prevent microthrombi that might otherwise block narrow channels and invalidate measured signals. This interaction could also facilitate the separation of plasma from red blood cells, ensuring that clear plasma reaches the medical diagnostic sensorfor more accurate analysis. Functional alternatives to heparinization include PEGylation (Polyethylene Glycol coating) to create a “stealth” surface that prevents protein adhesion, or Fluorinated Lubricant-Infused Surfaces (SLIPS) to prevent the aqueous biological materialfrom adhering to the biocompatible materialof the chamber walls entirely.
1 9 FIGS.- 10 62 12 14 18 44 28 12 46 36 12 40 12 42 44 12 48 In a preferred implementation of the method, and as shown in, the integrated analysis systemexecutes the rapid measuring and recording of data from a host. The method comprises utilizing a fully enclosed flow chamberwith a top surfaceand an interior spaceto perform quantitative measurements of aqueous biological material. The material is inserted into the flow channelsof the fully enclosed flow chamberusing clinical specimen collection equipment. The process involves housing medical diagnostic sensorswithin the fully enclosed flow chamberto capture quantitative measurements and utilizing a remote access devicein wireless communication with the fully enclosed flow chamberto rapidly process host data through artificial intelligence processing units. To prevent coagulation and contamination of the aqueous biological material, the method employs a fully enclosed flow chambercomposed of biocompatible material.
38 12 46 24 20 16 44 28 18 20 22 44 66 46 The method further includes attaching memory cartridgesto the fully enclosed flow chamberand removably connecting the clinical specimen collection equipmentat an injection pointof a passagewaylocated at the bottom surface. This arrangement facilitates the rapid transmission of the aqueous biological materialthrough a plurality of flow channelsfixedly attached within the interior space. By providing a passagewayas a substantially circular hollow tubeon a substantially vertical axis, the method enables a pump force insertion of the aqueous biological materialvia a manual user-actuated plunger mechanismattached to the clinical specimen collection equipment.
20 26 28 32 28 30 30 50 26 14 44 34 The application of the pump force moves the material rapidly through the passagewayinto a central distribution hub, and subsequently through the flow channelswhich are provided in an interconnected branched arrangement. The method involves directing the material to the outer endsof the flow channels, where it is received by the plurality of microtubes. By positioning the plurality of microtubesbelow the vertical planeof the central distribution huband beneath the top surface, the method prevents flow reversal of the aqueous biological materialand ensures the material remains in a stationary position within the interior compartmentsfor individual analysis.
36 68 62 44 28 42 38 36 58 During the analysis phase, the method utilizes the medical diagnostic sensorsto track in vivo and in vitro physical and chemical parametersof the host. This includes applying standard electrochemical principles—such as pH detection, ion-selective electrodes (Na, K, Ca), and neurotransmitter detection—once the aqueous biological materialis pumped into the flow channels. The artificial intelligence processing unitsincorporate machine learning algorithms to analyze data in real time, exchanging information between the memory cartridgesand medical diagnostic sensorsvia a local internal bus. This process employs predictive analytics to enhance measurement accuracy and executes artificial intelligence verification of the monitored data.
28 20 30 56 14 40 70 30 68 Finally, the method includes enclosing the radial arrangement of the flow channels, passageway, and microtubesby fixing a glass slidehorizontally across the top surface. The remote access deviceenables remote monitoring and control of the system, interpreting measured signalsto provide quantitative measurements of concentration, flow rate, and cellular characteristics. The method may perform a five-point analysis through the plurality of microtubes, allowing for simultaneous analysis of physical and chemical parametersto provide a comprehensive diagnostic workup.
10 44 12 46 64 46 30 44 28 56 14 12 The method further provides for the integrated analysis systemto facilitate the collection of an aqueous biological materialby removably connecting the fully enclosed flow chamberto clinical specimen collection equipment. In addition to a pre-filled syringe, the method may utilize various types of clinical specimen collection equipmentcommonly used in healthcare settings, such as blood collection tubes, vacutainers, swabs, specimen containers, or needles, to ensure the proper collection, preservation, and transport of samples into the microtubes. To protect the aqueous biological materialand the radial arrangement of the flow channels, the method includes horizontally extending a glass slideacross the top surfaceand fixing it thereon. As an alternative embodiment of the method, the user may select other cover materials for the fully enclosed flow chamber, such as quartz, plastic, or silicone coverslips, based on required optical properties, chemical resistance, and durability.
40 10 36 34 30 68 44 36 44 70 70 40 42 68 For data management and system oversight, the method utilizes at least one remote access deviceto enable the remote monitoring and control of the integrated analysis system. The medical diagnostic sensorintegrated within the interior compartmentsof the microtubesis configured to measure one or more parametersof the aqueous biological material, including but not limited to, concentration, flow rate, or cellular characteristics. By maintaining the medical diagnostic sensorin direct contact with the aqueous biological material, the method accurately captures measured signals. These measured signalsmay include scattered light measurements, fluorescence, or changes in electrical properties, which are then processed and interpreted by the remote access devicevia the artificial intelligence processing unitsto provide a quantitative measurement of the parametersbeing assessed.
10 30 68 42 62 42 36 36 operating The method of the integrated analysis systemas provided herein is designed to provide preliminary or detailed information that is reliable and can immediately guide clinical decisions in emergency situations. For example, in the case of a trauma patient where a blood count is immediately required, the method involves using the device to determine the need for a blood transfusion or the administration of additional blood or crystalloid fluids. When utilizing more than one microtubeto measure multiple parameters, the method includes the artificial intelligence processing unitsin cooperation with the history of the hostto provide early examination findings. The artificial intelligence processing unitsfacilitate locating a differential diagnosis, providing therapeutic recommendations, and managing test results from the medical diagnostic sensors. These monitoring steps can be performed on-scene, allowing a first-responder to initiate diagnostics and initial medical management using the available artificial intelligence and medical diagnostic sensorinformation. Such recommendations may include supplying blood and fluids, improving breathing support, or providing ventilation based on cardiac, respiratory, or trauma-related etiologies.
62 10 62 36 68 In the case of an unconscious host, the method includes utilizing the systemto recommend a blood gas analysis to determine the necessary respiratory support or fluid volume. The method guides immediate resuscitation or fluid decisions by providing a blood gas analysis, including the partial pressure of carbon dioxide, partial pressure of oxygen, and base excess, to indicate the lung and metabolic status of the host. The method further provides for whole blood diagnostics, including blood type determination and evaluation, hematologic concerns such as a complete blood count, and biochemical analysis of electrolytes and liver function. Additionally, the method allows for the measurement of biomarkers including C-reactive protein, procalcitonin, and interferon via the medical diagnostic sensorto provide a comprehensive quantitative measurement of the parametersbeing assessed.
44 62 10 36 70 42 62 In various clinical settings, the method comprises collecting aqueous biological material, such as blood or spinal fluid, from a hostfor diagnostic purposes. While the integrated analysis systemis frequently employed for human patients, the methodology further provides for diagnostic testing, disease monitoring, and research in veterinary settings, biomedical research on non-human primates, or the analysis of any organism that harbors pathogens or parasites. By utilizing the medical diagnostic sensorto capture measured signalsacross diverse biological environments, the method ensures that the artificial intelligence processing unitscan provide reliable quantitative measurements regardless of the hostspecies.
44 30 36 36 44 The methodology involves managing the type and amount of aqueous biological materialplaced within each microtube, which typically includes a fraction of a CC (e.g., 0.1-0.3 CC), though this volume may be reduced or increased based on the specific medical response scenario and setting. For example, the method includes detecting bacterial or viral pathogens within a small sample using integrated PCR technology as a medical diagnostic sensor. In such an embodiment, the medical diagnostic sensoris prepared with a specific film to detect target viruses or bacteria to provide a bacterial match in a blood sample. Furthermore, the method provides for using smaller samples of aqueous biological materialfor non-invasive prenatal DNA testing, wherein a mother's blood is analyzed to determine fetal risk for certain abnormalities by evaluating small fragments of cell-free DNA circulating in the maternal bloodstream.
1 FIG. 10 44 42 42 38 As illustrated in, the method provides for secondary analysis following the preliminary or in-the-field analysis performed by the integrated analysis system. For example, the method may include further hematologic analysis at a core laboratory to determine a complete blood count, including white blood cells, hematocrit, hemoglobin, and platelet count. Following the complete labeling of the aqueous biological materialfor further diagnosis and immunological analysis, the method provides for the differentiation of white blood cells using a flow cytometry process to automate the results. During this process, the artificial intelligence processing unitsexecute a learning protocol, improving the accuracy of new output data and results over time. By utilizing specific machine learning algorithms, the artificial intelligence processing unitsprocess the stored data from the memory cartridgeto provide additional clinical conclusions and interpretations.
2 FIG. 3 FIG. 6 FIG. 42 44 36 68 As shown in, the methodology further includes performing a secondary cellular analysis to detect the presence of specific immune cells and discern the distribution of immune cells within a sample. With reference toand, the method involves utilizing specific algorithms within the artificial intelligence processing unitsto identify the positive or negative influences of inflammation on the brain-intestine axis. The method tracks how an inflammatory response in the GI system may correlate with inflammation in the brain, such as by measuring increased levels of interferon released into the aqueous biological material. By utilizing the medical diagnostic sensorto analyze spinal fluid, the method detects the possibility of infection or inflammatory processes affecting the brain or nerve fibers as a non-invasive alternative to a brain biopsy. The method further involves monitoring mediators and pro-inflammatory or anti-inflammatory proteins released by immune cells to assess their impact on both local environments, such as the bowels, and remote organs. Through the analysis of parameterswithin the microbiome, the method enables the identification of contributing factors to neuro-developmental problems, such as inflammatory responses causing tissue scarring or affecting synapse development, rather than relying solely on the detection of a brain bleed.
12 30 36 44 Overall, the design of the fully enclosed flow chamberand the microtubeused to hold a medical diagnostic sensorand aqueous biological materialis aimed at providing a convenient and reliable repository for the measurement of specific parameters in such materials, while ensuring safety, reliability, accuracy, and ease of use in a clinical or point-of-care setting.
12 The fully enclosed flow chamberand associated parts can be constructed in various sizes and can be provided as standard construction including the provision of durable materials for all elements as provided herein. It can be produced in a circular shape, a standard box-like shape or provided as desired by a particular healthcare facility. In a healthcare setting, the shape of a medical device plays a crucial role in facilitating easy and efficient handling of biological materials such as blood. The device's ergonomic design ensures that it can be comfortably held, operated, and easily integrated into the workflow of a healthcare professional.
12 30 36 48 48 12 30 The design of the fully enclosed flow chamberand microtubescan vary depending on the specific application and the type of medical diagnostic sensorsbeing used and can be made of biocompatible materialsto ensure that the materials do not alter the composition of the biological materials. Common materials might include medical-grade plastics or polymers. The biocompatible materialcan be chosen to minimize interaction with whole blood or similar biological materials, thereby preserving the original sample compositions and prevent coagulation and similar conditions that can affect the analysis. The fully enclosed flow chamberand microtubescan be designed to be disposable and single-use to prevent cross-contamination and ensure the accuracy of subsequent measurements.
30 44 36 30 34 36 36 30 36 30 58 36 30 The microtubemay include features such as capillary action channels or microfluidic pathways to enable the efficient movement of the aqueous biological materialto the medical diagnostic sensor. The microtubeincludes interior compartmentswhere the medical diagnostic sensoris inserted and the medical diagnostic sensorcan be positioned to have direct contact with the biological materials and thereby allowing for the measurement of the desired parameter. The design of the microtubeensures that the medical diagnostic sensorremains securely in place and properly aligned to enable accurate measurements. In some cases, the microtubemay include electrical contacts, optical windows, or other local internal businterfaces that allow the medical diagnostic sensorto communicate with external measurement or analysis equipment. The microtubemay also include features to ensure proper alignment and connection with the measurement device or instrument.
12 36 30 12 30 36 The protective cover is a safety feature that prevents accidental exposure to the biological material. Additional safety features such as tamper-evident seals for the fully enclosed flow chamberand the medical diagnostic sensorcompartment may also be incorporated to minimize the risk of exposure to biohazards during the handling and disposal of the microtube. The fully enclosed flow chamberand the microtubemay also include markings, labels, or identifiers to convey important information such as the type of medical diagnostic sensor, lot number, expiration date, and any specific handling instructions.
42 58 38 36 42 60 44 42 The method provides for the integration of artificial intelligence processing unitsbased on the specific requirements and constraints of a facility, utilizing a local internal busto facilitate the exchange of data between the memory cartridges, medical diagnostic sensors, and the artificial intelligence processing units. This integration may involve establishing wireless connections via a wireless transmitteror utilizing wired connections to incorporate artificial intelligence into the evaluation system. The method leverages this architecture to enhance the accuracy and efficiency of the analysis of the aqueous biological materialand to improve the effectiveness of medical diagnostics and patient care. Specifically, the method includes identifying patterns, anomalies, and trends within the biological sample data via the artificial intelligence processing unitsto assist in diagnosing medical conditions, predicting patient outcomes, and providing insights for medical research. Furthermore, the methodology involves processing data to reinforce the medical conclusions of healthcare professionals by providing data-driven insights and recommendations to support the construction of clinical opinions regarding specific treatment methods or plans, while ensuring adherence to regulatory standards, privacy considerations, and ethical guidelines.
10 38 36 44 38 36 68 70 The method further comprises configuring the mechanical, wireless, and electrical connections of the integrated analysis systemaccording to the specific design requirements of the memory cartridge, the medical diagnostic sensors, and the specific evaluation of the aqueous biological material. In a medical context, the methodology includes adhering to relevant industry and regulatory standards for medical devices to ensure the safety and effectiveness of all system interconnections. By managing the interface between the memory cartridgeand the medical diagnostic sensor, the method ensures the reliable capture and storage of parametersand measured signalsduring the biological material evaluation process.
12 38 38 38 Certain components necessary to the operation of the memory device or other parts of the fully enclosed flow chamberare not shown or described in detail because they are components well known to those in the relevant arts. These components include well-known components, attachments, parts, and operations. For example, a memory cartridgein a general sense is a storage device designed to hold digital data and the function of the memory cartridgewill vary depending on the specific application in a healthcare setting. A few common functions of the memory cartridgeas provided herein can include storage and retrieval of digital data such as files, documents, images, and software.
38 12 36 44 38 12 12 Physically connecting memory cartridgesto a fully enclosed flow chamberand to a series of medical diagnostic sensorsfor evaluating samples of aqueous biological materialinvolves a plurality of considerations regarding mechanical, wireless, and electrical connections. The design as provided herein considers the compatible physical dimensions and connections between a specific memory cartridgeand a fully enclosed flow chamberto ensure a secure mechanical connection. Given the medical nature of the fully enclosed flow chamber, the mechanical connection should be durable and able to withstand repeated use and potential sterilization processes. The mechanical connection should be designed for easy insertion and removal to facilitate the workflow of biological material evaluation.
38 36 60 40 If wireless communication is used, the memory cartridgeand medical diagnostic sensorsshould support a reliable wireless protocol for transmitting data via a wireless transmitterto the remote access device. This could be Bluetooth, Wi-Fi, or another suitable wireless standard. If sensitive patient data is being transmitted wirelessly, the connection should incorporate appropriate security measures to protect the data from unauthorized access or interception.
12 38 36 58 38 36 The fully enclosed flow chamber, memory cartridge, and medical diagnostic sensorscan have a consistent power supply, whether through batteries, charging, or another power source and the electrical connection can support the transfer of data via the local internal busbetween the memory cartridge, the medical diagnostic sensors, and ensuring that information from the biological material evaluation is accurately stored and accessible.
38 12 36 44 38 12 The method provides for the physical connecting of a memory cartridgeto a fully enclosed flow chamberand to a series of medical diagnostic sensorsto evaluate samples of aqueous biological material. This process involves managing compatible physical dimensions and connections between a specific memory cartridgeand the fully enclosed flow chamberto ensure a secure mechanical connection. The methodology includes utilizing mechanical connections designed for durability to withstand repeated use and potential sterilization processes, while facilitating the workflow of biological material evaluation through easy insertion and removal.
38 36 60 40 If wireless communication is employed, the method involves utilizing a memory cartridgeand medical diagnostic sensorsthat support a reliable wireless protocol for transmitting data via a wireless transmitterto the remote access device. This step may include implementing protocols such as Bluetooth, Wi-Fi, or other suitable wireless standards. Furthermore, when transmitting sensitive patient data, the method includes incorporating appropriate security measures to protect the data from unauthorized access or interception during wireless transmission.
12 38 36 58 38 36 72 68 70 The methodology further comprises maintaining a consistent power supply for the fully enclosed flow chamber, memory cartridge, and medical diagnostic sensors, whether through batteries, charging, or an alternative power source. This ensures that the electrical connections support the transfer of data via the local internal busbetween the memory cartridgeand the medical diagnostic sensors. By maintaining these power and data interfaces, the method ensures that information from the biological material evaluation, including all parametersand measured signals, is accurately stored and remains accessible for analysis.
While the invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof.
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